Benzinga | Sep 15, 2021 08:32AM EDT

Coherus, Junshi Biosciences Announce Results From Phase 3 Study Of Toripalimab Published In September Issue Of Nature Medicine

Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) and Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) today announced publication of a cover article in the September issue of Nature Medicine featuring clinical data from the pivotal study "JUPITER-02", a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC).



Titled Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial, the paper highlights that the addition of toripalimab to standard of care gemcitabine-cisplatin (GP) chemotherapy as a first-line treatment for patients with recurrent or metastatic NPC provided superior progression free survival (PFS) compared to GP alone [median PFS of 11.7 vs 8.0 months, hazard ratio (HR) = 0.52 (95% confidence interval (CI): 0.36--0.74), P = 0.0003], and with a manageable safety profile. The impact of the addition of toripalimab on PFS was demonstrated in patients regardless of PD-L1 expression status. Although overall survival data were not yet mature, as of February 18, 2021, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.603 (95% CI: 0.364--0.997)). The incidence of grade ?3 treatment emergent adverse events (TEAEs) (89.0% vs 89.5%), TEAEs leading to discontinuation of toripalimab/placebo (7.5% vs 4.9%), and fatal TEAEs (2.7% vs 2.8%) was similar between both arms. Immune-related adverse events (irAEs) (39.7% vs. 18.9%) and Grade ?3 irAEs (7.5% vs. 0.7%) were more frequent in the toripalimab arm. The full results can be found in the on-line edition of Nature Medicine.

"There are currently no PD-1 blocking antibodies approved for NPC in the United States. We are pleased that this study has been selected for cover article publication in this highly-respected journal," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "This is a strong signal that further validates the potential advance that toripalimab in combination with chemotherapy would represent as a new standard-of-care first-line therapy for patients with advanced NPC, an aggressive and difficult-to-treat cancer."

A biologics license application has been submitted to the U.S. Food and Drug Administration ("FDA") for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.